This presentation discusses some of the unique impacts on the clinical trial process for Monitors, Sites, and Sponsors as they adopt electronic source records.

1. eSource: Changing the
Monitor / Site / Sponsor
Relationship
Edward S. Seguine
CEO
Clinical Ink

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3. Discussion Points
• What is eSource?
• Industry Metrics
• Business Model Implications
Audience Participation REQUIRED

4. Vote via Texting
22333
22333
176644

5. Practice Poll
Poll: My primary work role is:

6. What is eSource?
Digital Equipment
(BP Cuff, EKG)
IVRS / IWRS
ePRO
Imaging Data EMRs ??

7. FDA “We’re Here To Help”
Electronic Source Documentation
“This guidance is intended to promote the
capture of source data in electronic form, which
will help to:
– eliminate unnecessary duplication of data,
– reduce transcription errors,
– promote real-time entry of electronic source during
subject visits,
– ensure accurate/complete data through electronic
prompts”

8. FDA Perspective
“For the purpose of this guidance, the terms eSource
documents and eSource data are used to describe source
documents and source data for which the original record
and certified copies are initially captured electronically.”
(page 6)
“The eCRF is a vehicle used to assemble all the data from
different electronic- and paper-based systems and makes
it possible to capture and organize these diverse data in a
manner that satisfies the study protocol and that enables
the data to be systematically reviewed and analyzed.”
(page 6)

9. FDA “We’re Here To Help”
Risk-Based Monitoring
“The guidance specifically encourages greater use of
centralized monitoring methods where appropriate…
The extent to which centralized monitoring practices
can be employed will depend to some extent on
accessibility of electronic records.” (page 1, 8)
“Source data verification and other activities
traditionally performed by on-site monitoring can now
often be accomplished remotely.” (page 5)

10. Poll #1
Poll: How much was spent on Phase 1-3 Clinical...

11. Poll #1
How much was spent on Phase 1-3
clinical trials last year?
$40 BILLION
$1,200,000 for EVERY employee
involved in clinical trials

12. Total Clinical Trial Costs
5% 4%
6%
12% 26%
18%
29%
Source: Medidata CRO Contractor Fact Sheet; June 2012

13. Monitoring Spend
R&D Spend Monitoring
Phase 1 $5.6B $1.2B
Phase 2 $8.8B $2.7B
Phase 3 $25.4B $7.9B
TOTAL $39.8B $11.8B
Source: 2012 PhRMA Industry Report
UNSUSTAINABLE!

14. Clinical Trials Today
# Days Task Category
0 Record patient data on paper forms SOURCE
2 – 10+ Manually input data into database EDC
On-site comparison of Source to
30 – 60+ MONITOR
EDC

15. Clinical Trials Tomorrow
# Days Task Benefit
0 Record patient data on electronic forms No Paper
0 Automatically record to database No Errors
0 Remotely review source docs via web No Travel

16. Poll #2
Poll: Direct entry into CRFs meets site GCP re...

17. Source ≠ CRF
Explicit FDA requirements for Source
21 CFR 312.62(b) Patient Case History
Criteria Source CRF
Timing Original Secondary
Workflow Site/Subject Sponsor
GCP/Protocol; Analysis;
Data
Unstructured Structured
Owner Investigator Sponsor
Validation Review Verify

18. Source ≠ CRF: PE - eCRF
CDASH Preferred Option A (5.14.1)
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19. Source ≠ CRF: PE – Paper Source
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20. Source ≠ CRF: PE – eSource
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21. CRF ≠ Source: Vitals - eCRF
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22. CRF ≠ Source: Vitals – Paper Source

23. CRF ≠ Source: Vitals – eSource

24. Poll #3
Poll: Reviewing CRFs remotely is sufficient to...

25. Site Responsibility for Source
Inadequate/inaccurate case history is 2ND
most common site audit finding
“Failure to maintain adequate and accurate case histories that
record all observations and other data pertinent to the
investigation” - cited in 60% of investigator warning letters
“What is not documented is not done”
ICH E6 separates source DOCUMENTS from
source DATA

26. Impact on Monitoring Plan
Source Data Verification: what data does
need to be verified for accuracy
Source Document Review: what documents
should be reviewed for context, trends, etc.
Remote Monitoring: what types of trial data,
how frequently, with what tools
Changing Source data: where will changes be
made, by whom, when, where is audit trail

27. Monitor – Site Communication
Fewer onsite visits, but more frequent and
relevant site interactions
Data clarified by viewing context of document
Queries - total number and response time are
reduced
Centralized tools „track‟ monitor activity; what
% of documents reviewed, how long?

28. Practical Realities
At what level is data signed? Investigator
“signs” CRF, do they need to “sign” eSource
eSource design intent versus database;
difference between “Yes”, “No”, “Null” values
Eliminate duplicate edit checks; if checked at
source, no need for second check
Not all site employees have email address;
how to verify identity, grant access

29. Drawbacks of Targeted SDV
Reliance on EDC data - not Source
No source document review
No benefit to site workflow
Sponsor discretion and risk
Sounds new; but really old
Reliance on process, not technology

30. Contact Details
Ed Seguine
CEO – Clinical Ink
336-464-0702
eseguine@clinicalink.com
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